WHO Modifies HIV Guidelines, Says Stop Using Stavudine

The most commonly used antiretroviral for HIV, stavudine, should be phased out, recommends the World Health Organization (WHO), because the drug is associated with “long-term, irreversible” side effects. WHO has also issued other new treatment guidelines for HIV patients.

An estimated 33.4 million people around the world have HIV/AIDS, according to the WHO, and about 2.7 million new infections occur each year. Among women of reproductive age, HIV/AIDS is the leading cause of death.

One new recommendation by the WHO that may have an impact on this latter statistic is that people with HIV, including pregnant women, should begin taking antiretroviral drugs earlier to improve their chances of living a longer, healthier life. The WHO is now also advising HIV-positive women and their infants to take the drugs while breastfeeding to prevent transmission of the virus from mother to child. The new mother-to-child transmission recommendations have the potential to reduce the HIV transmission risk to 5 percent or lower in this population.

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Another major WHO recommendation concerns stavudine, which is also known as d4T. This drug is widely used in developing countries as a first-line therapy for HIV because it is easy to use and inexpensive. Serious side effects, however, such as wasting (a loss of body fat known as lipoatrophy) and a nerve disorder that leads to numbness and burning pain, are associated with its use. The drug is marketed as Zerit by Bristol-Myers Squibb Co. but is also available in generic versions through several companies in India.

Alternatives to stavudine include the less toxic zidovudine (AZT), which was first made by GlaxoSmithKline Plc. The patent expired in 2005, and now generic versions are available. Another safe alternative is tenofovir, which is marketed by Gilead Sciences as Viread.

The WHO press release noted that if its recommendations are adopted, the result will be a greater number of people needing treatment for HIV. The costs associated with earlier treatment may be offset by a decline in HIV infections, decreased hospital costs, increased productivity because people take fewer sick days, and fewer children orphaned by AIDS.

About 50 percent of the more than 4 million people around the world who take antiretrovirals use stavudine, a drug that the Food and Drug Administration first approved for adults in 1994 and for pediatrics in 1996. The WHO has noted that it will provide technical support to countries to make the transition to new antiretrovirals and to adopt and implement the other revised WHO guidelines.